UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035436 |
|---|---|
| Receipt number | R000040369 |
| Scientific Title | Effects of transcranial Alternating Current Stimulation (tACS) on brain network of healthy young |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2020/02/28 19:29:35 |
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Basic information
Public title
Effects of transcranial Alternating Current Stimulation (tACS) on brain network of healthy young
Acronym
ETACS
Scientific Title
Effects of transcranial Alternating Current Stimulation (tACS) on brain network of healthy young
Scientific Title:Acronym
ETACS
Region
| Japan |
Condition
Condition
Healthy young
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to evaluate the effect of transcranial alternating electrical stimulation on brain function by functional connectivity estimated by resting functional MRI.
Basic objectives2
Others
Basic objectives -Others
none.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional connectivity just after tACS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
tACS 6Hz 10min 1mA
Interventions/Control_2
shame
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)20 years old or more.
2)no history of neurological and psychiatric disease.
3)applicability for MRI.
4)informed consent.
Key exclusion criteria
none.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Onoda |
Organization
Shimane University
Division name
Department of Neurology
Zip code
Address
89-1, Enyacho, Izumo
TEL
0853202343
onodak1@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Onoda |
Organization
Shimane University
Division name
Department of Neurology
Zip code
Address
89-1, Enyacho, Izumo
TEL
0853202343
Homepage URL
onodak1@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040369
